Virtue Sirolimus-Eluting Balloon Helps Prevent Restenosis without Stents

When plaques cause arterial vessels to narrow, intravascular balloons are usually used to widen the lumen. Sirolimus and its analogues are drugs that are commonly used to prevent restenosis. Because blood flows rapidly through, stents coated with the drug have been used to treat the area by slowly releasing sirolimus and the like into the surrounding vascular tissue. The problem is that the stent has to stay, which may create its own side effects.

Now a new device, called Virtue Sirolimus-Eluting Balloon (SEB), from Orchestra BioMed, a company based in New Hope, Pennsylvania, may soon be a new treatment option without having to leave anything behind. The SEB is an angioplasty balloon, and so is able to push plaque apart, but it also has tiny holes through which sirolimus microparticles can exit. These particles are conglomerations of sirolimus molecules, which get embedded into the vascular tissue. They slowly break down, releasing small amounts of the drug, which acts to prevent restenosis.

The Virtue balloon just received Breakthrough Device Designation from the FDA, which will help speed it through the regulatory process, potentially receiving final FDA approval real soon.

Here’s a video from Orchestra BioMed presenting its Virtue SEB:

Product page: Virtue Sirolimus-Eluting Balloon (SEB)…

Via: Orchestra BioMed…